1. Field of the Invention
This invention relates to a device for occluding a body passage. More particularly, this invention relates to a device for controlling flow of fluids through a body passage acting much like a sphincter.
2. Brief Description of the Prior Art
Incontinence is the inability to voluntarily control the discharge of excretory materials. The condition may be caused by physical, neurological or psychological traumas. Incontinence is a major medical problem that affects several million Americans of all ages. This condition is the source of public stigma, often forcing those affected to withdraw from regular social activities.
Recently, surgical processes and devices have been developed to address and treat incontinence. Many of the surgical processes employ devices that occlude the affected body passage. Inflatable fluid actuated artificial sphincters are one type of such known devices for occluding body passages, especially the urethra.
Artificial sphincters now available include an inflatable cuff configured to surround and occlude the body passage, a pump and a bulb type reservoir. There are two types of reservoir bulbs available--a nonexpandable pressure variable bulb and an expandable constant pressure type bulb. The basic components are connected by fluid transmission lines. One conduit or fluid transmission line connects the cuff with the pump. A second conduit or fluid transmission line connects the pump with the reservoir bulb.
The cuff is inflated to occlude the body passage and deflated to allow the discharge of fluid through the body passage. The cuff is maintained in a normally inflated (closed) position.
The presently available fluid actuated artificial spincters have proven to be effective. However, there are some problems associated with present systems. For instance, the components of presently available devices are separately implanted.
The reservoir bulbs now used are implanted in separate area away from the cuff and other components. Separate implantation increases the time required to surgically implant the device. Consequently, it would be desirable to remove the need to separately implant the reservoir bulb.
The presence of any implant can cause irritation to the surrounding tissue. Increasing the number of components separately implanted will effect more tissue. Irritated tissue must adapt to the implanted components before the sphincter should be activated. Otherwise, the body may reject the implant, or worse cause infection.
In some cases, even though the surrounding tissue is allowed to adapt, the expansion and contraction of the constant pressure reservoir bulbs will cause erosion and scarring. Consequently, it is desirable to reduce the number and size of the components implanted.
The problems discussed are not meant to be exhaustive of the problems associated with the present device. Rather, the problems disclosed are meant to be illustrative of potential areas of improvement.